Navigation Bronchoscopy vs CT-Guided Biopsy for Lung Nodules

(VERITAS Trial)

No longer recruiting at 6 trial locations

Overseen By Vanderbilt-Ingram Service for Timely Access

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt-Ingram Cancer Center

Disqualifiers: Proximal nodules, Multiple nodules, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for obtaining a biopsy (a small tissue sample) from a lung nodule, which is a growth in the lung. One method uses a CT-guided biopsy to reach the nodule from outside the chest, while the other uses navigation bronchoscopy to access it through the airways. The trial aims to determine which method is more effective for nodules that meet specific size and location criteria. Suitable participants have a single lung nodule measuring 10 to 30 mm, located in the middle or outer area of the lung. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially enhance biopsy techniques for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these biopsy procedures are safe for lung nodule evaluation?

Research has shown that navigation bronchoscopy is generally safe for diagnosing lung nodules. In studies involving over 1,000 nodules, this method proved safe, with serious side effects being rare and a lower risk of a collapsed lung compared to other methods.

CT-guided biopsy also maintains a good safety record and is well-tolerated by most patients. However, it carries a slightly higher risk of a collapsed lung than navigation bronchoscopy.

Both procedures are considered safe, with navigation bronchoscopy having slightly fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different methods for diagnosing lung nodules: navigation bronchoscopy and CT-guided biopsy. Navigation bronchoscopy is unique because it uses a highly advanced, real-time GPS-like system to guide the bronchoscope directly to the lung nodule, potentially making it less invasive and more precise than traditional methods. On the other hand, CT-guided biopsy, while commonly used, involves using imaging technology to guide a needle to the nodule, which can sometimes be more invasive. Researchers hope to find out if navigation bronchoscopy can provide a safer, more effective way to obtain tissue samples from lung nodules compared to the standard CT-guided approach.

What evidence suggests that this trial's procedures could be effective for lung nodule biopsy?

This trial will compare Navigation Bronchoscopy with CT-Guided Biopsy for diagnosing lung nodules. Studies have shown that navigation bronchoscopy effectively diagnoses lung nodules, sometimes achieving a 100% success rate. It matches the effectiveness of the traditional CT-guided biopsy but involves fewer complications. In terms of accuracy, navigation bronchoscopy is as reliable as a needle biopsy, a common method for diagnosing lung nodules. CT-guided biopsy has traditionally been used and is known for effectively sampling lung nodules from outside the chest. In summary, both procedures perform well, but navigation bronchoscopy might offer a safer option with similar accuracy. ^{1 6 7 8 9}

Who Is on the Research Team?

Fabien Maldonado, MD

Principal Investigator

Vanderbilt-Ingram Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with a single lung nodule sized between 10 and 30 mm, located in the middle or outer parts of the lungs. They should have an intermediate chance of cancer (10-100%) based on specific prediction models. The nodule must be reachable by both navigation bronchoscopy and CT-guided biopsy as confirmed by experts.

Inclusion Criteria

The size of the tumor is between 10 and 30 millimeters in its longest part.

Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either: The Brock model14 if no PET scan data are available, or The Herder model15 if PET-CT data are available.

Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.

Exclusion Criteria

Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).

My lung nodules are not in the top third of my lung.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo either a CT-guided biopsy or navigation bronchoscopy to obtain a lung nodule biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for diagnostic accuracy and safety outcomes, including pneumothorax and need for additional procedures

12 months

What Are the Treatments Tested in This Trial?

Interventions

• CT-Guided Biopsy
• Navigation bronchoscopy

Trial Overview

The study compares two procedures to biopsy lung nodules: navigation bronchoscopy, which uses airways to reach the growth, and CT-guided biopsy, where a needle goes through the chest wall with CT scan guidance. It aims to find out which method is best for certain lung nodules.

How Is the Trial Designed?

Group I: Navigation Bronchoscopy (NB) with F-Nav Experimental Treatment 1 Intervention

Group II: CT-guided Biopsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5384894/

Navigation bronchoscopy for diagnosis and small nodule ...

Similarly, Awais et al. (45) found a success rate of 100% for the localization of 33 lung nodules with a median size of 10 mm (range, 4–27 ...

2.

news.vumc.org

news.vumc.org/2025/05/18/study-finds-navigational-bronchoscopy-as-effective-and-safer-alternative-to-transthoracic-biopsy-for-lung-nodules/

Study finds navigational bronchoscopy as effective and ...

Navigational bronchoscopy is as effective as the traditionally used transthoracic needle biopsy for diagnosing lung nodules, but with significantly fewer ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12340260/

Narrative review of diagnostic yield of navigational ...

The Acquire Registry study, which assessed the DY of bronchoscopy for PPL, reported an overall DY of 53.7%, as it did not use follow-up and only included cases ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0169500223007341

Diagnostic yield and safety of navigation bronchoscopy

This systematic review analyses the diagnostic yield and safety of navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules suspected of lung ...

5.

breakthroughsforphysicians.nm.org

breakthroughsforphysicians.nm.org/pulmonary-research-article-lung-nodules-biopsy-strategies

Navigational Bronchoscopy vs Needle Biopsy

A NEJM study shows navigational bronchoscopy matches needle biopsy in accuracy while greatly reducing complications for lung nodule diagnosis.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24401166/

Diagnostic yield and safety of electromagnetic navigation ...

Results: A total of 15 trials were included (1,033 lung nodules). A positive and definitive diagnosis was obtained after 64.9% of all ENB ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8107026/

Diagnostic yield and safety of biopsy guided by ...

In conclusion, ENB‐guided biopsy for high‐risk pulmonary nodules showed an acceptable diagnostic yield and a good safety profile. Moreover, the diagnostic yield ...

8.

jwatch.org

jwatch.org/na58845/2025/06/18/safer-method-diagnosing-peripheral-pulmonary-nodules

A Safer Method for Diagnosing Peripheral Pulmonary ...

Image-guided NavBr is safer than TTNB (e.g., less risk for pneumothorax) but historically less effective for sampling peripheral nodules.

9.

chestpulmonary.org

chestpulmonary.org/article/S2949-7892(24)00016-3/fulltext

Navigational Bronchoscopy vs CT Scan-Guided ...

The results of this rigorously designed trial will provide high-quality data regarding the management of lung nodules, a common clinical entity ...